Evaluation of the Safety and Preliminary Immunogenicity of Inactivated Rotavirus Vaccine (Vero Cell) in Healthy Population: a Randomized, Double-blind, Placebo Parallel-controlled Phase I Clinical Trial

This study is a randomized, double-blinded, placebo-controlled, Phase 1, dose-escalation study to evaluate the safety, reactogenicity and immunogenicity of Inactivated Rotavirus Vaccine (IRV) performed in healthy adult (aged 18-49 years), adolescent (aged 6-17 years) and infant subjects (aged 2-71 months). Primary objectives of the clinical trial include assessing the safety and tolerability of IRV given at two and three dose levels and comparing the safety and tolerability of IRV after each vaccination, between dosage groups, and by pre-vaccination rotavirus immune status. Secondary objective of the clinical trial is immunogenicity evaluation after each vaccination, between dosage groups, and by pre-vaccination rotavirus immune status.

开始日期2020-12-03

申办/合作机构

中国医学科学院

NCT06209398

/ Active, not recruiting临床4期IIT

Study on the Immunogenicity and Safety of Inactivated Enterovirus Type 71 Vaccine Combined Administration With Recombinant Hepatitis B and Group A Meningococcal Vaccine

The main purpose of this study is to evaluate the immunogenicity and safety of inactivated enterovirus type 71 vaccine combined with recombinant hepatitis B vaccine or Group a meningococcal polysaccharide vaccine.

开始日期2018-05-24

申办/合作机构

Jiangsu Province Centers for Disease Control and Prevention

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100 项与肠道病毒71型灭活疫苗 (中国医学科学院) 相关的临床结果

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项与肠道病毒71型灭活疫苗 (中国医学科学院) 相关的文献（医药）

2021-07-01·Biotechnology letters4区 · 工程技术

MiR-103/miR-107 inhibits enterovirus 71 replication and facilitates type I interferon response by regulating SOCS3/STAT3 pathway

4区 · 工程技术

Article

作者: Huang, Baizhi ; Zheng, Yanbing ; Chen, Haiping

BACKGROUND:

Enterovirus71 (EV71), the major cause of hand, foot, and-mouth disease (HFMD), has increasingly become a public health challenge. Type I interferons (IFNs) can regulate innate and adaptive immune responses to pathogens. MicroRNAs (miRNAs) play regulatory roles in host innate immune responses to viral infections. However, the roles of miR-103 and miR-107 in EV71 infection remain unclear.

METHODS:

Quantitative real-time polymerase chain reaction (qRT-PCR) was employed to determine the expression of miR-103, miR-107, suppressor of cytokine signaling 3 (SOCS3), VP1, IFN-α, and IFN-β. Virus titers were measured by 50% tissue culture infectious dose (TCID₅₀) assay. Western blot assay was conducted to detect the protein levels of VP1, IFN-α, IFN-β, SOCS3, signal transducer and activator of transcription 3 (STAT3), and phospho-STAT3 (p-STAT3). Immunofluorescence assay was used to detect the protein level of VP1. The concentrations of IFN-α and IFN-β were examined by Enzyme-linked immunosorbent assay (ELISA). The interaction between SOCS3 and miR-103/miR-107 was predicted by starBase and verified by dual-luciferase reporter assay and RNA pull-down assay.

RESULTS:

MiR-103 and miR-107 were downregulated and SOCS3 was upregulated in serum from patients with EV71 and EV71-infected cells. Overexpression of miR-103 and miR-107 repressed EV71 replication by inhibiting EV71 titers and VP1 expression. Moreover, upregulation of miR-103 and miR-107 enhanced EV71-triggered the production of type I IFNs. In addition, miR-103 and miR-107 directly targeted SOCS3, and SOCS3 upregulation reversed the effects of miR-103 and miR-107 on EV71 replication and type I IFN response. Importantly, miR-103 and miR-107 increased STAT3 phosphorylation by targeting SOCS3 after EV71 infection.

CONCLUSION:

MiR-103 and miR-107 suppressed EV71 replication and increased the production of type I IFNs by regulating SOCS3/STAT3 pathway, which might provide a novel strategy for developing effective antiviral therapy.

2021-03-01·Food and environmental virology3区 · 医学

Viral Interference as a Factor of False-Negative in the Infectious Adenovirus Detection Using Integrated Cell Culture-PCR with a BGM Cell Line

3区 · 医学

Article

作者: Oishi, Wakana ; Watanabe, Ryosuke ; Amarasiri, Mohan ; Sano, Daisuke ; Kitajima, Masaaki ; Okabe, Satoshi

This study investigated the influence of viral interference on the detection of enteric viruses using the integrated cell culture (ICC)-PCR with a BGM cell line. It was possible to detect 10² plaque-forming units (PFU)/flask of enterovirus 71 (EV71) in spite of the presence of 10⁴ PFU/flask of adenovirus 40 (AdV40). Meanwhile, 10⁴ PFU/flask of AdV40 was not detected in the presence of 10² PFU/flask of EV71. This inhibition of AdV40 detection using ICC-PCR was attributable to the growth of EV71, because the addition of a growth inhibitor of EV71 (rupintrivir) neutralized the detection inhibition of AdV40. The growth inhibition of AdV40 under co-infection with EV71 is probably caused by the immune responses of EV71-infected cells. AdV is frequently used as a fecal contamination indicator of environmental water, but this study demonstrated that false-negative detection of infectious AdV using ICC-PCR could be caused by the co-existence of infectious EV in a water sample. The addition of rupintrivir could prevent false-negative detection of AdV using ICC-PCR. This study, therefore, emphasizes the importance of confirming the presence of multiple enteric viruses in a sample derived from environmental water prior to the application of ICC-PCR because the viral interference phenomenon may lead to the false-negative detection of target viruses.

2015-12-01·BMC medicine1区 · 医学

Immunity and clinical efficacy of an inactivated enterovirus 71 vaccine in healthy Chinese children: a report of further observations

1区 · 医学

ArticleOA

作者: Li, Rongcheng ; Ong, Kien Chai ; Zhou, Zhenxin ; Wang, Xuanyi ; Cui, Pingfang ; Mo, Zhaojun ; Che, Yanchun ; Cui, Wei ; Li, Qihan ; Wang, Junzhi ; Jiang, Li ; Feng, Min ; Zhang, Ying ; Wang, Jingjing ; Xie, Zhongping ; Pu, Jing ; Liang, Zhenglun ; Shi, Haijing ; Wang, Lichun ; Xia, Jielai ; Liao, Yun ; Wong, Kum Thong ; Wang, Ling ; Zhao, Hongling ; Huang, Teng ; Guo, Lei ; David, Perera ; Liu, Longding ; Tan, Soon Hao ; Yang, Erxia ; Dong, Chenghong ; Mao, Qunying ; Liang, Yan ; Na, Ruixiong

BACKGROUND:

To investigate the long-term effects on immunity of an inactivated enterovirus 71 (EV71) vaccine and its protective efficacy.

METHODS:

A sub-cohort of 1,100 volunteers from Guangxi Province in China was eligible for enrolment and randomly administered either the EV71 vaccine or a placebo on days 0 and 28 in a phase III clinical trial and then observed for the following 2 years with approval by an independent ethics committee of Guangxi Zhuang Autonomous Region, China. Serum samples from the 350 participants who provided a full series of blood samples (at all the sampling points) within the 2-year period were collected. Vaccine-induced immune effects, including the neutralizing antibody titres and cross-protection against different genotypes of EV71, were examined. This study also evaluated the protective efficacy of this vaccine based upon clinical diagnosis.

RESULTS:

This sub-cohort showed a >60% drop-out rate over 2 years. The seroconversion rates among the 161 immunized subjects remained >95% at the end of study. The geometric mean titres of neutralizing antibodies (anti-genotype C4) 360 days after vaccination in 350 subjects were 81.0 (subjects aged 6-11 months), 98.4 (12-23 months), 95.0 (24-35 months), and 81.8 (36-71 months). These titres subsequently increased to 423.1, 659.0, 545.0, and 321.9, respectively, at 540 days post-immunization (d.p.i.), and similar levels were maintained at 720 d.p.i. Higher IFN-γ/IL-4-specific responses to the C4 genotype of EV71 and cross-neutralization reactivity against major EV71 genotype strains were observed in the vaccine group compared to those in the placebo group. Five EV71-infected subjects were observed in the placebo-treated control group and none in the vaccine-immunized group in per-protocol analysis.

CONCLUSION:

These results are consistent with the induction of dynamic immune responses and protective efficacy of the vaccine against most circulating EV71 strains.

TRIAL REGISTRATION NUMBER:

Clinicaltrials.gov, NCT01569581, Trial registration date: March 2012.

项与肠道病毒71型灭活疫苗 (中国医学科学院) 相关的新闻（医药）

2025-11-17

·天津市市场监督管理委员会

天津市药品监督管理局对疫苗委托储存配送情况信息公告（2025年第22号）

天津市药品监督管理局对疫苗委托储存配送情况信息公告（2025年第22号）为强化疫苗生产及疫苗储存配送企业的质量主体责任，接受社会各界对疫苗储存配送质量监督，根据国家药监局关于发布《疫苗生产流通管理规定》的公告（2022年第55号）、食品药品监管总局国家卫生计生委《关于进一步加强疫苗流通监管促进疫苗供应工作的通知》（食药监药化监〔2017〕76号）和天津市市场监管委《关于进一步加强疫苗流通和质量监管的通知》（津市场监管流通[2017]84号）要求，现就中国医学科学院医学生物学研究所等企业报告疫苗委托储存配送情况信息公告如下：委托企业名称委托企业注册地址委托品种目录被委托企业名称被委托企业注册地址被委托企业仓储地址委托配送区域区域仓储（有/无）委托配送合同有效期中国医学科学院医学生物学研究所云南省昆明市茭菱路935号肠道病毒71型灭活疫苗(人二倍体细胞)（国药准字S20150016）国药控股天津有限公司天津市和平区小白楼街道宝融大厦2号楼大连道1号二至五层(二层201-204、206、207、211、213室，三层302、303、312、314、315室除外) 天津市空港经济区东八道53号天津市区域配送、天津市区域储仓储有 2025年12月01日肠道病毒71型灭活疫苗(人二倍体细胞)（国药准字S20150016） Sabin株脊髓灰质炎灭活疫苗(Vero细胞)（国药准字S20150002） Sabin株脊髓灰质炎灭活疫苗(Vero细胞)（国药准字S20217023）冻干甲型肝炎减毒活疫苗（国药准字S20060007）北京科兴中维生物技术有限公司北京市大兴区中关村科技园大兴生物医药产业基地天富街21号1号楼吸附破伤风疫苗（药品批准文号：国药准字S20250048，药品有效期：24个月）北京钥途冷运物流有限公司北京市顺义区机场北街8号院2幢4层E402室 N/A 天津市（干线运输（从疫苗生产企业直接运输至县级疾病预防控制机构））无至2027年06月29日重庆智飞生物制品股份有限公司重庆市江北区庆云路1号50层 23价肺炎球菌多糖疫苗（药品批准文号：国药准字SJ20181013）口服五价重配轮状病毒减毒活疫苗（Vero细胞)（药品批准文号：国药准字SJ20180002）四价人乳头瘤病毒疫苗（酿酒酵母）（药品批准文号：国药准字SJ20170037）九价人乳头瘤病毒疫苗（酿酒酵母）（药品批准文号：国药准字SJ20180008）重组带状疱疹疫苗(CHO细胞)（药品批准文号：国药准字SJ20190026）顺丰医药供应链有限公司广州市越秀区东风东路776号603房（含夹层） N/A 天津市（干线运输（从疫苗生产企业直接运输至县级疾病预防控制机构）、区域配送）无 2026年12月31日

2023-09-12

·药创客

肠道病毒71型-柯萨奇病毒A16型二价灭活疫苗（人二倍体细胞）疫苗临床申请获批，来自中国医学科学院医学生物学研究所

点击上方图片链接报名EV71-CA16临床获批NEWS”中国医学科学院医学生物学研究所（医科院生物所）肠道病毒71型-柯萨奇病毒A16型二价灭活疫苗（人二倍体细胞）疫苗临床申请获批，该疫苗的目标适用人群为6月龄-5岁人群，医科院生物所将于近期启动相关临床试验。手足口病（HFMD）是由肠道病毒（Enterovirus, EV）感染引起的一种儿童常见传染病，5岁以下儿童多发。以发热及手、足、口等部位斑丘疹或疱疹为主要特征，多数患儿一周左右自愈，少数患儿可见神经系统感染引起的神经源性肺水肿、无菌性脑膜炎、脑炎、迟缓性麻痹等严重神经系统疾病，预后差，病死率较高。手足口病是我国报道病例最多的传染病。自2008年5月起，我国将手足口病纳入法定报告丙类传染病，累计已造成超2600万例的感染。2010-2022年，全国报告手足口病远多于病毒性肝炎、肺结核、流感等常见传染病。HFMD严重危害儿童健康，已然成为一个严重的公共卫生问题。其中，肠道病毒71型（Enterovirus 71, EV71）是引起手足口病重症和死亡病例的主要病原。随着2015年医科院生物所等三个厂家研发生产的疫苗上市使用，HFMD的流行趋势得到了相应的控制，但针对该疾病的病原学研究已经表明，除了EV71之外，主要的病原还包括柯萨奇A组16型病毒（Coxsackievirus A16）。因此，控制儿童手足口病的发生，使用针对二种以上病原抗原（至少为EV71/CA16）的疫苗是极为必要的。EV71灭活疫苗是我国自主研制的、全球唯一可预防EV71导致的手足口病重症和死亡病例的新型疫苗。2015年12月，由医科院生物所研制生产的、全球首剂预防6~71月龄儿童由EV71感染导致手足口病的、生物制品1类新药，宜维福Ⓡ肠道病毒71型灭活疫苗（人二倍体细胞）获批上市。宜维福Ⓡ是我国领先研发的创新性疫苗，真正实现了从概念到实践的创新，它的上市，是中国疫苗由“中国制造”向“中国创造”转变的里程碑式的标志性产品。EV71灭活疫苗目前已对我国31个省、自治区、直辖市的4000余万名婴幼儿使用，我国手足口病死亡人数明显下降，至2018及2019年已较疫苗上市前的平均死亡人数下降了92.7%和95.8%，有效控制了我国的EV71疫情*。2021年4月18日，中国医学科学院首次发布了2项“中国21世纪重要医学成就”全球首创以肠道病毒71型(EV71)疫苗预防重症手足口病“本次遴选的目的在于凝练本世纪以来我国医学科技取得的成绩，更多考虑的是其对国家医疗卫生事业发展、医学科技的进展以及解决人民健康问题的价值和意义，注重其对社会的持续影响。”宜维福Ⓡ入选第一批“中国21世纪重要医学成就”。根据国家疾控局发布的全国法定传染病疫情概况，今年6、7月份，手足口病报告发病人数出现急速增长，单月报告超40万病例，甚至超过2016年疫苗初上市时的同期数值。手足口病的防治仍在面临巨大的挑战，肠道病毒71型-柯萨奇病毒A16型二价灭活病毒疫苗的研发，将为预防手足口病提供新的利器！识别微信二维码，添加小编，符合条件者即可申请加入微信群！请注明：姓名+单位！声明：本文旨在传递更多信息，版权归原作者所有。原创文章转载均需经过授权并注明来源，如涉及内容、版权或其他问题请时联系小编删除！文章仅代表作者个人观点，并不代表公众号立场。本公众号拥有对此声明的最终解释权！投稿邮箱：yck19876@163.com

疫苗临床研究临床终止

100 项与肠道病毒71型灭活疫苗 (中国医学科学院) 相关的药物交易

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研发状态

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适应症	国家/地区	公司	日期
手足口病	中国	中国医学科学院医学生物学研究所	2015-12-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01569581 (Pubmed \| BMC Med)	临床3期	-	12,000	EV71 vaccine	鏇齋窪築艱繭繭鏇繭夢(襯淵壓糧製衊製遞衊齋) = 鹽齋網壓糧襯簾繭鏇蓋鏇糧遞積餘艱夢製觸築 (糧鹹醖範獵齋構餘窪餘 )	-	2015-09-17
				Placebo	糧觸夢醖鹹製構蓋觸鹹(鬱顧鏇憲鑰遞夢鹹淵鏇) = 窪願淵製簾夢憲齋簾範襯積艱遞遞獵鬱壓窪選 (鑰鑰網膚網衊齋鑰觸積 )
NCT01569581 (Pubmed \| N Engl J Med)	临床3期	-	-	Inactivated EV71 vaccine	膚壓鏇築願顧簾憲範築(襯顧憲齋衊範襯構膚顧) = 願糧積遞繭艱襯窪淵觸鏇獵膚淵夢憲鑰範淵積 (蓋遞簾蓋製鬱獵觸窪鬱 ) 更多	积极	2014-02-27
				Placebo	膚壓鏇築願顧簾憲範築(襯顧憲齋衊範襯構膚顧) = 憲艱窪憲鹹膚壓鹹簾繭鏇獵膚淵夢憲鑰範淵積 (蓋遞簾蓋製鬱獵觸窪鬱 )